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510(k) Data Aggregation

    K Number
    K170902
    Device Name
    Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit
    Manufacturer
    SPR Therapeutics, LLC
    Date Cleared
    2017-06-26

    (90 days)

    Product Code
    NHI
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPR Therapeutics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days in the back and/or extremities for: - · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; - · Symptomatic relief of post-traumatic pain; - · Symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to treat pain in the craniofacial region.
    Device Description
    The Sprint PNS System is comprised of a percutaneous electrode placed via an introducer needle in proximity to a target peripheral nerve associated with a painful area and a wearable external stimulator that delivers stimulation therapy to the percutaneous electrode. The Sprint PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted through the skin via an introducer needle and remain indwelling for the duration of the therapy (up to 60 days).
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    K Number
    K161154
    Device Name
    Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
    Manufacturer
    SPR THERAPEUTICS, LLC
    Date Cleared
    2016-07-23

    (89 days)

    Product Code
    NHI
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPR THERAPEUTICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smartpatch Peripheral Nerve Stimulation (PNS) System is indicated for up to 30 days in the back and/or extremities for: - · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; - · Symptomatic relief of post-traumatic pain; - · Symptomatic relief of post-operative pain. The Smartpatch PNS System is not intended to treat pain in the craniofacial region.
    Device Description
    The Smartpatch PNS System is comprised of a percutaneous electrode placed via an introducer needle in proximity to a target peripheral nerve associated with a painful area and a wearable external stimulator that delivers stimulation therapy to the percutaneous electrode. The Smartpatch PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted through the skin via an introducer needle and remain indwelling for the duration of the therapy (up to 30 days). The diameter of the wire is 0.26mm. The wire is provided in two lengths (20cm, 40cm) with a maximum placement depth of approximately 10cm.
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